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Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage

NCT06968481 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2026-04-23

No results posted yet for this study

Summary

An open-label, randomized, single-center, dose ascending trial will be conducted to evaluate the efficacy and safety of sublingual oxytocin for the prevention of post-partum hemorrhage caused by uterine atony in term pregnant women having an uncomplicated vaginal delivery.

Conditions

  • Post Partum Hemorrhage

Interventions

DRUG

Oxytocin sublingual

Sublingual oxytocin 1000 IU, 3000 IU or 6000 IU

DRUG

Oxytocin IM

Intramuscular oxytocin 10 IU

Sponsors & Collaborators

  • Insud Pharma

    lead INDUSTRY

Principal Investigators

  • Enrico Colli, MD · Chemo Research SL

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-30
Primary Completion
2026-10-30
Completion
2026-10-30

Countries

  • Nigeria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06968481 on ClinicalTrials.gov